Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Immunotherapy

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Solid tumour winners and losers at ASCO20

Do any of the early trials in advanced cancers aspire to be great?

Not in Chicago – Of relevance to the ongoing ASCO20 coverage, in the Preview series this year, two of the companies we highlighted going into the meeting (Innovent and Alphamab) both announced deals this week with Roche and Sanofi, respectively – talk about highlighting hot topics ahead of time 😉

After last week’s look at winners and losers in hematologic malignancies, this time around we now turn our attention to explore what’s happening on the new product development front regarding solid tumours.  In this review, we critique some of the trials presented and put them in broader context.

As always, there are both some important learnings we can glean as well as some, well, head/desk moments to contemplate…

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Hematology Winners and Losers at ASCO20

Not in Chicago: It’s that time of the year when my inbox rapidly fills up with folks wanting to know which were selections our winners and losers from the annual ASCO meeting.

Happy or surreal days?

There are several different ways we can organise this analysis such as Top 10 selections, by company, by trials, by product, by tumour type, by disease setting etc. The first is undoubtedly easier and shorter to write, but in general it’s really hard to pick five winners and five losers to debate and some years are more mixed in any case.

At BSB we almost rarely think about oncology R&D in terms of companies, stocks, or even individual studies per se, so this leaves organising products by tumour type and subsets.

In part 1 today we are going to focus on hematology and key developments in this area. What was under-rated, over-rated and what bombed?

There are several developments which made our short list and here we cover the highs and lows as well as a pithy ratings scale at the end. Be warned, there are likely a few surprises in store…

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A rock around the breast cancer clock

Sadly not the #blisterwalk this year

Not in Chicago – Breast cancer has been a hot topic again on several fronts after a bit of a lull on the R&D front.

Writing about such trials across ESMO Breast, ASCO and the second AACR meeting is all very well, but what about some KOL commentary and reactions to some of the data we get to see?

If this has been a burning question for you, this is a handy article to catch up on. Of course, to be clear – not all the trials will be positive or biomarker analysis helpful, so here we tackle the issue and look at what’s what though the lens of a specialist…

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Can we add fire to the immune system with TIGIT?

Not in Chicago: We continue our ASCO coverage with a look at the evolving TIGIT landscape and the initial tiragolumab data in lung cancer.

With all the breathless hype of late one wonders if some observers believe (accompanied by loud trumpeting of horns) this is the next big checkpoint target after CTLA-4 and PD(L)1, but is it?  The field has barely got started with a raft of new trials opening to evaluate several molecules in different combinations across solid tumours, and yet we have something of a fanfare already.

Will TIGIT roar and fire up the immune system in some people with cancer or will it fizzle out?

To those of us familiar with new product development and early stage development the ‘hot’ status is likely leaving us somewhat bemused at the noise around the emerging targets, after all it’s going to be a long while before we see those all important phase 3 readouts with appropriate head-to-head comparisons.

In this latest article, we take a look at the Genentech antibody, tiragolumab, and also discuss the development with a company executive to gain their perspectives, insights and rationale on what was behind the recent trial expansions beyond the phase 1 study in advanced solid cancers.

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A false dawn in adjuvant EGFR mutant lung cancer? Dr Ross Camidge provides a critical review of ADAURA

Not in Chicago: A hallmark of the annual meeting of the American Society of Clinical Oncology (ASCO) is “practice changing” clinical trial data often featured in the plenary session.

This year one of the noteworthy phase 3 trials presented at the meeting (link to ASCO20 Abstract LBA5), was the AstraZeneca sponsored “ADAURA” trial for osimertinib as adjuvant therapy in patients with stage 1B-IIIA EGFR mutation-positive NSCLC after complete tumor resection.

We’ve been following the clinical development of osimertinib since the initial presentation of the phase 1 data in 2013 (link).

Source: ASCO20 Press Briefing by Dr Roy Herbst

At first glance it’s hard not to be wowed by the separation of the disease-free survival (DFS) curves in ADAURA, which show a benefit for patients who received the EGFR inhibitor osimertinib compared to those who received placebo. A 0.17 hazard ratio is certainly not something we see every day.

Indeed, if you were in the media and listened to Dr Herbst on the #ASCO20 press briefing last week – to use a “Britishism” – you would have thought this trial was “the best thing since sliced bread.”  The data monitoring committee recommended unblinding the study early.

Dr Ross Camidge Colorado

D Ross Camidge, MD PhD

Anyone leaving the story there and doing a superficial report about this data is, however, doing a disservice to their readers. The US academic lung cancer community are not all singing Handel’s Hallelujah chorus for the ADAURA trial and in this post, we take a critical look at why this might be the case.

For good measure, we interviewed a global thought leader who was prepared to offer some candid expert commentary.

Dr Ross Camidge is Professor of Medicine/Oncology and holds the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado school of medicine. He kindly spoke to BSB and shared his perspective on adjuvant therapy in EGFR mutant lung cancer.

Dr Camidge characterized the disease-free survival in the ADAURA trial as a potential “false dawn” and told BSB:

“I do not believe the data should be practice changing or at least not yet. I think when you show there is an overall survival benefit then it will be practice changing…

So far there is no reason to suggest that disease free survival is going to translate into an overall survival advantage as it has not in any other comparable targeted therapy trial in EGFR mutant lung cancer. If this trial is the exception though, it will certainly not be of the same magnitude as the DFS benefit. However, the real unanswered questions are who needs this drug in this setting and if they need it, who can stop it safely and when.”

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Reflections on bench to bedside progress

Time for some reflections from ASCO

Many eyes at ASCO this weekend will be eagerly turned towards the plenary session on Sunday and the stunning osimertinib data in the ADAURA (adjuvant osimertinib therapy for EGFR positive disease) where 69% were stage II/IIIA and for those patients, DFS HR was 0.17 with a 2 year DFS rate of 90% (only 44% with placebo).

There is no doubt this is the data of the meeting for me – when was the last time we saw a hazard ratio of 0.17?! More on this development after the data has been presented.

Beyond the plenary there are plenty of interesting studies to discuss and ponder at various stages of development. Over the next couple of days a number of other stories and interviews will be also posted.

Here, we provide an update on one of the early drug development stories we’ve been following longitudinally over the last five years from preclinical through to the clinic and offer some reflections on progress to date.

A KOL interview and commentary are included as well…

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What to watch out for in Developmental Therapeutics at ASCO20

It occurred to me after several such events this year that virtual meetings create a very different pattern for spectators from live events where we all dash from one hall to another trying to optimise the viewing experience and catch as many key talks as we can.

Gems from the ASCO Poster Halls

Instead of the annual rugby scrum in the ASCO poster halls, we can imagine ourselves in an entirely different world with social distancing virtually

Many people will no doubt be eager to listen to the various oral presentations of phase 3 data come Friday morning, while the poor posters may well languish until some undetermined time later, so why not take a step back and highlight some of the early work in developmental therapeutics ahead of time?

In the final part of our ASCO Preview series, we offer our independent take and candid commentary on ten abstracts in developmental therapeutics to watch out for.

A word of warning – we don’t take a particular perspective through the lens of rose tinted glasses, so not all the analyses are positive and there are some firm words against some of the selections regarding continued development or the researchers conclusions/recommendations.

Some of these are agents in early development, some are biomarkers or even emerging trends, but all are intriguing in their own unique fashion.

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What’s new in advanced breast cancer?

This weekend in the oncology conference calendar saw the ESMO Breast meeting take place.

The event was originally planned as a live event in Berlin – sadly with the pandemic it ended up as a virtual meeting on Central European time, yet you can still imagine the Berlin bear welcoming everyone regardless of format!

This is a good time to take off we we left off last week with our SERD landscape review since there was some new clinical data presented in this niche, as well as segue to the ASCO meeting on Friday where other companies will also be showcasing their early data.

Aside from SERDs, there were plenty of other highlights and commentary to consider in advanced breast cancer.

Here we explore some of the findings and offer some context for at least one commercial showdown…

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Will the next generation SERDs make an impact in ER+ HER2- breast cancer?

It’s time for another landscape review of a particular class of drugs in early development.

Here we take an in-depth look at the emerging SERD landscape in ER+ metastatic breast cancer. There’s a lot going on the ER+HER2- niche these days after a bit of a lull once we saw the CDK4/6 inhibitors approved so it’s a good opportunity for some extended colour commentary on what could become a hot area in oncology over the next couple of years.

Overcoming or delaying the onset of therapeutic resistance is going to be important, but how do we go about achieving this?

Historically we have seen some success in inhibiting the activity of the estrogen receptor (ER) as a driver of oncogenic activity, but what if we could degrade the aberrant protein instead? Would this approach yield some further benefits for people with advanced breast cancer?

There are quite a few companies, big and small, involved in this space so there’s still much to play for, especially in terms of figuring out what the ideal drug should look like and which combinations might be most useful. We also highlight key upcoming conference presentations to watch out for – hint: there’s quite a lot of them!

To learn more from our oncology analysis and get a heads up on insights and commentary emerging from the ASCO and second AACR virtual meetings, subscribers can log-in or you can click to gain access to BSB Premium Content.

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ASCO20 Preview on the importance of modality in oncology R&D

Continuing our ASCO20 coverage with another Preview in the pre-meeting series, we turn our attention to a particular modality of keen interest to many of our readers.

In this latest article, we highlight ten areas within the niche and include an array of companies, both big and small, across Pharma and Biotechs.

Some of them have some nice data to share, others will be footnotes to the meeting, but who fits into what category and what can we learn from the abstracts upfront?

To find out more, we looked very carefully at the hints and nuance which inevitably grace the writer’s pen – it’s time to hone in on where are the flourishes and the crossings out this year?

To learn more from our oncology analysis and get a heads up on insights and commentary emerging from the ASCO meeting, subscribers can log-in or you can click to gain access to BSB Premium Content.

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